MAUDE Adverse Event Report: ANIMAS LLC ANIMAS VIBE; INSULIN INFUSION PUMP

Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pump has not been returned to animas.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.
Event or Problem Description
On (b)(6) 2019, the reporter contacted animas alleging that the patient had a blood glucose (bg) in the low teens associated with an alleged inaccurate delivery issue.It was unknown if the patient remained on the pump, but it was reported that emergency medical services were notified.It was also unknown if the patient received any treatment.During troubleshooting with customer technical support, the reporter stated there were six separate incidents between (b)(6) and (b)(6) 2018.The reporter recalled that there was an episode that occurred on (b)(6) 2018 and (b)(6) 2018.The reporter stated that the patient had a blood glucose of 19 mg/dl at one point but could not remember what the exact bg was for each episode.Customer technical support (cts) was unable to determine what the issues were with the pump.Troubleshooting could not be completed at the time of the complaint.Cts made attempts to contact the reporter for additional information and troubleshooting, without success.This complaint is being reported based on the allegation that the patient experienced hypoglycemia due to issues with the pump.The pump could not be ruled out as a contributing factor.

• Brand Name: ANIMAS VIBE
• Common Device Name: INSULIN INFUSION PUMP
• Manufacturer (Section D): ANIMAS LLC; 965 chesterbrook blvd; wayne PA 19087
• MDR Report Key: 8487839
• Report Number: 2531779-2019-02435
• Device Sequence Number: 19505352
• Product Code: OYC
• UDI-Device Identifier: 10840406100266
• UDI-Public: 10840406100266
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P130007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 19 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 55 YR
• Patient Weight: 207